Hawkins Point Partners Computer System Validation/ Business System Analyst in Cambridge, Massachusetts
Hawkins Point Partners is looking for CSV Analyst / Business Systems Analyst to join our Quality & Validation team.
Person must be a mid- senior level able to independently drive tactical tasks to completion such as developing SOP’s, working with business teams to review vendor documents and complete CSV deliverables. Flexible and able to scale approaches based on phase, risk and business needs. Analytical risk-based decision maker able to solution and document decisions using technical writing skills.
Experience writing Functional Specifications, Design Specifications, Risk Management Assessment / Report, Test Plan/Test scripts, test summary reports, validation summary, and validation documents.
Awareness and in-depth knowledge of CSV (GxP), especially clinical.
Ability to work with business to complete new and retrospective System impact assessments.
Update and manage system inventory
Support CSV projects as back up when needed
At Hawkins Point Partners we believe in creating great experiences for our colleagues. We offer competitive compensation along with comprehensive benefit options to meet the diverse needs of our colleagues in their personal and professional lives.